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Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema

Primary Purpose

Pulmonary Emphysema

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Emphysema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of severe heterogeneous emphysema (heterogeneity > 15%), with heterogeneity defined as the difference between lobes in the percent area covered by parenchymal density greater than -950 Hounsfield Units.
  • Estimation of collateral ventilation based on fissure with integrity ≥ 75%.
  • Total lung capacity> 100% predicted.
  • Residual volume> 150% predicted.
  • Forced expiratory volume at the first minute <45% predicted.
  • Diffusing capacity of the lungs for carbon monoxide <45% predicted.
  • Optimal medical treatment.
  • Limitations in daily physical activities.
  • Minimum of 4 months without smoking
  • Having family support.
  • Stage ≥ 2 in modified Medical Research Council Dyspnea Scale (MMRC).

Exclusion Criteria:

  • Homogenous emphysema.
  • Presence of collateral ventilation.
  • Use of systemic corticosteroids (prednisone> 20mg/day or equivalent).
  • Pulmonary or extrapulmonary infection.
  • Coronary heart disease and/or severe ventricular dysfunction.
  • Significant renal or liver disease.
  • Immunosuppressive disease.
  • Active smoking.
  • Cancer prognosis with survival <2 years.
  • Psychosocial problems.
  • Pregnancy.

Sites / Locations

  • Pontificia Universidade Catolica do Parana
  • Universidade Federal do Rio de Janeiro
  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Valves plus cells

Valves plus saline

Arm Description

Bronchoscopy Five patients will be selected to receive bone-marrow derived mesenchymal stromal cells delivered bronchoscopically right before insertion of one-way endobronchial valves.

Bronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion.

Outcomes

Primary Outcome Measures

Absence of lung deficits during the procedure and/or in the 4 months follow-up

Secondary Outcome Measures

Quality of Life
St. George Respiratory Questionnaire
Pulmonary function
Spirometry, flow-volume curve, post-bronchodilator test, determination of residual volume, airway resistance by plethysmography, diffusing capacity of the lung for carbon monoxide, and six-minute walk test
Inflammation
Collection of blood samples for determination of C-reactive protein (CRP), erythrocyte

Full Information

First Posted
June 5, 2013
Last Updated
March 24, 2015
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Ministry of Health, Brazil, National Research Council, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Universidade Federal do Rio de Janeiro, Pontifícia Universidade Católica do Paraná
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1. Study Identification

Unique Protocol Identification Number
NCT01872624
Brief Title
Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema
Official Title
Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Ministry of Health, Brazil, National Research Council, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Universidade Federal do Rio de Janeiro, Pontifícia Universidade Católica do Paraná

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal cells in patients with severe pulmonary emphysema is safe and will contribute to increase quality of life.
Detailed Description
In addition to testing the safety of one-way endobronchial valves combined with bone-marrow derived mesenchymal stromal cells, the study will determine the systemic inflammatory potential of cell therapy measured by C-reactive protein levels (CRP), erythrocyte sedimentation rate (ESR) and complete blood count in peripheral blood. Finally, the study will aim at determining if other markers of inflammatory response and remodeling are modulated by this therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valves plus cells
Arm Type
Active Comparator
Arm Description
Bronchoscopy Five patients will be selected to receive bone-marrow derived mesenchymal stromal cells delivered bronchoscopically right before insertion of one-way endobronchial valves.
Arm Title
Valves plus saline
Arm Type
Placebo Comparator
Arm Description
Bronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion.
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Intervention Description
Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.
Primary Outcome Measure Information:
Title
Absence of lung deficits during the procedure and/or in the 4 months follow-up
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
St. George Respiratory Questionnaire
Time Frame
120 days
Title
Pulmonary function
Description
Spirometry, flow-volume curve, post-bronchodilator test, determination of residual volume, airway resistance by plethysmography, diffusing capacity of the lung for carbon monoxide, and six-minute walk test
Time Frame
120 days
Title
Inflammation
Description
Collection of blood samples for determination of C-reactive protein (CRP), erythrocyte
Time Frame
120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of severe heterogeneous emphysema (heterogeneity > 15%), with heterogeneity defined as the difference between lobes in the percent area covered by parenchymal density greater than -950 Hounsfield Units. Estimation of collateral ventilation based on fissure with integrity ≥ 75%. Total lung capacity> 100% predicted. Residual volume> 150% predicted. Forced expiratory volume at the first minute <45% predicted. Diffusing capacity of the lungs for carbon monoxide <45% predicted. Optimal medical treatment. Limitations in daily physical activities. Minimum of 4 months without smoking Having family support. Stage ≥ 2 in modified Medical Research Council Dyspnea Scale (MMRC). Exclusion Criteria: Homogenous emphysema. Presence of collateral ventilation. Use of systemic corticosteroids (prednisone> 20mg/day or equivalent). Pulmonary or extrapulmonary infection. Coronary heart disease and/or severe ventricular dysfunction. Significant renal or liver disease. Immunosuppressive disease. Active smoking. Cancer prognosis with survival <2 years. Psychosocial problems. Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo G Oliveira, MD, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia RM Rocco, MD, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontificia Universidade Catolica do Parana
City
Curitiba
State/Province
PR
ZIP/Postal Code
80215-901
Country
Brazil
Facility Name
Universidade Federal do Rio de Janeiro
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-902
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21656291
Citation
Abreu SC, Antunes MA, Pelosi P, Morales MM, Rocco PR. Mechanisms of cellular therapy in respiratory diseases. Intensive Care Med. 2011 Sep;37(9):1421-31. doi: 10.1007/s00134-011-2268-3. Epub 2011 Jun 9.
Results Reference
background
PubMed Identifier
16840401
Citation
de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190.
Results Reference
background

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Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema

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